Study Start-Up Lead

Key responsibilities:

• Integrates SSU insights into the trial Operational Execution Plan (OEP), ensuring alignment with milestones and dashboards alongside the Study Leader/CTT.
• Oversees trial-specific setup of SSU systems, including tasks, personnel, vendors, translations, site contracting tools, and templates (e.g., ICF, enrollment plans). Prepares SSU planning and leads the SSU Team from kick-off through completion for global site enrollment, adhering to timelines and trial requirements.
• Ensures timely collection of global trial-level documents for submission and eTMF entry, supporting health authority and Ethics Committee approvals.
• Collaborates with Vendor Program Manager and GCS to ensure vendor activation, site readiness, and clinical supply alignment for site initiation.
• Provides proactive oversight, managing risks to ensure quality SSU execution and adherence to timelines/regulations, implementing corrective actions if required.
• Ensures the proper use of technology platforms, completeness of data, and alignment of global budgets/processes to support SSU activities and timelines. Enables and oversees country Study Start-up Managers to ensure local submission package readiness, IRB/IEC approvals, and timely delivery of SSU deliverables.

Essential requirements:

• Degree in scientific or health discipline required; advanced degree with clinical trial and/or project management experience preferred.
• Fluent English, spoken and written.
• Minimum 2 years overseeing and/or monitoring clinical trials, plus 1 year contributing to their planning, execution, and reporting. Proven ability to engage and lead diverse teams in a global, matrixed environment.
• Excellent influencing, communication, and negotiation abilities at all organizational levels.
• Strong understanding of Good Clinical Practice, clinical trial design, and global drug development processes.
• Experience with electronic systems, clinical/project management analytics, and willingness to embrace new technologies.
• Data-driven mindset and dedication to meeting deadlines effectively.

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